ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

A TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE USING THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE FOR INSURANCE PURPOSES AT APPROX 4:30 P.M. EASTERN TIME. THE PROCEDURE FOR THE COLLECTION OF THE ORAL FLUID SAMPLE WAS PERFORMED ACCORDING TO THE PRODUCT INSERT, PART NUMBER 203-0014, ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE, REVISION NUMBER THREE. THE TEST SUBJECT PLACED THE COLLECTION PAD INSIDE THEIR MOUTH WITH THE PAD SIDE ORIENTED DOWN BETWEEN THE LOWER GUM AND CHEEK AND GENTLY RUBBED THE PAD BACK AND FORTH ALONG THE GUM LINE UNTIL THE PAD WAS MOIST. THE TEST SUBJECT LEFT THE PAD STATIONARY AGAINST THE LOWER GUM AND CHEEK FOR A MINIMUM TWO MINS AND LESS THAN FIVE MINS. AT THE END OF THE TWO MINS, THE TEST SUBJECT REMOVED THE COLLECTION PAD FROM THEIR MOUTH AND INSERTED IT ALL THE WAY TO THE BOTTOM OF THE SPECIMEN VIAL PROVIDED BY THE ADMINISTRATOR. THE TEST SUBJECT SNAPPED OFF THE STICK AND RETURNED THE SPECIMEN VIAL TO THE ADMINISTRATOR. AFTER RUBBING THE PAD ALONG THE GUM LINE, THE TEST SUBJECT FELT A SENSATION THAT STARTED AT THE POINT OF CONTACT WITH THE DEVICE AND MOVED THROUGHOUT THEIR HEAD AND GAVE THE PT A HEADACHE. AFTER PROVIDING THE COLLECTION THE PT EXPERIENCED SHORTNESS OF BREATH. THE TEST SUBJECT STATED THAT THE PT WAS RELAXED ABOUT PROVIDING THE ORAL FLUID SAMPLE. THE TEST SUBJECT WAS FEELING BETTER THAT EVENING, APPROX 7:30 P.M. EASTERN TIME, BUT THE SPOUSE REPORTED THE COMPLAINT BECAUSE THE PT WAS CONCERNED THE DEVICE MIGHT CONTAIN SULFIDES. THE TEST SUBJECT IS ALLERGIC TO SULFIDES. THE CO'S CONSULTING PHYSICIAN CONTACTED THE TEST SUBJECT THE NEXT DAY TO DISCUSS THEIR SYMPTOMS AND THE INGREDIENTS OF THE DEVICE. THE TEST SUBJECT INFORMED HIM THAT THE PT HAD FULLY RECOVERED WITHOUT ILL EFFECTS. THE CONSULTING PHYSICIAN REASSURED THE PT AND ADVISED THE PT THAT THE PT SHOULD HAVE NO LONG TERM EFFECTS.